Mucoadhesive buccal dosage forms

• US 4,900,552 A
• Filed: 03/30/1988
• Issued: 02/13/1990
• Est. Priority Date: 03/30/1988
• Status: Expired due to Fees

• Current Assignee: Watson Laboratories, Inc. (Abbvie Incorporated)
• Original Assignee: Watson Laboratories, Inc. (Abbvie Incorporated)
• Inventors: Leung, Sau-Hung S., Sanvordeker, Dilip R.
• Primary Examiner(s): Swisher, Nancy
• Application Number:
  US07/175,075
• Time in Patent Office: 685 Days
• Field of Search: 424/435, 424/434, 424/422, 424/447, 424/448, 424/468
• US Class Current: 424/422
• CPC Class Codes: A61K 8/0208 Tissues; Wipes; Patches
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61Q 11/00 Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses

Abstract

A trilaminate film suitable for prolonged and sustained delivery of an active ingredient in a buccal cavity is disclosed. A hydratable mucoadhesive base layer, a non-adhesive reservoir layer and a water-impermeable carrier film sandwiched between and bonded to the base layer and the reservoir layer are the elements which form the trilaminate film.

Claims

1. A buccal dosage form suitable for delivery of an active ingredient in a buccal cavity and comprising:

a hydratable mucoadhesive base layer;

a non-adhesive reservoir layer; and

a water-impermeable barrier sandwiched between and bonded to said base layer and said reservoir layer;

said reservoir layer comprising a plasticized filmforming cellulose ester, a dehydrated hydrogel and said active ingredient to be dispersed directly into the buccal cavity; and

said water-impermeable barrier comprising a cellulose ester film.

2. The buccal dosage form in accordance with claim 1 wherein the mucoadhesive base layer is constituted by a member of the group consisting of water-swellable, but water-insoluble, fibrous, cross-linked carboxy-functional polymers, hydrophilic polysaccharide gums, cross-linked alignate gum gels, water-dispersible polycarboxylated vinyl polymers, and mixtures thereof.

3. The buccal dosage form in accordance with claim 2 wherein the hydrophilic polysaccharide gum is a member of the group consisting of a natural plant exudate and a seed gum.

4. The buccal dosage form in accordance with claim 2 wherein the hydrophilic polysaccharide gum is a member of the group consisting of karaya gum, ghatti gum, locust bean gum, guar gum, psillium seed gum and mixtures thereof.

5. The buccal dosage form in accordance with claim 1 wherein the cellulose ester film is a member of the group comprising of cellulose acetate butyrate, cellulose acetate isobutyrate, and cellulose acetate propionate.

6. The buccal dosage form in accordance with claim 1 wherein the weight ratio of cellulose ester to dehydrated hydrogel in the reservoir layer is in the range of about 7:

3 to about 1;

4, respectively.

7. The buccal dosage form in accordance with claim 1 wherein the weight ratio of cellulose ester to dehydrated hydrogel in the reservoir layer is in the range of about 6:

4 to about 1;

3, respectively.

8. The buccal dosage form in accordance with claim 1 wherein the hydrogel is a combination of a polyoxyalkylene block copolymer and alginic acid.

9. The buccal dosage form in accordance with claim 8 wherein the weight ratio of polyoxyalkylene block copolymer to alginic acid is about 5 to about 0.2, respectively.

10. The buccal dosage form in accordance with claim 8 wherein the polyoxyalkylene block copolymer contains oxyethylene chains and oxypropylene chains in a weight ratio of about 7:

3, respectively.